Glaukos Corporation (GKOS) Earnings Call Transcript & Summary

Good afternoon, everyone. I'm Robbie Marcus, the med tech analyst at JPMorgan. Very happy to introduce our next company. It's going to be CEO, Tom Burns, presenting for Glaukos. Lots of news flow today from the company. I feel honored. It's like a mini analyst day they've provided the JPMorgan conference here. So before we get to that, everyone can go to the conference website and follow along with the slide deck. You could submit a question there or you could e-mail me or chat me on Bloomberg, and I'll do my best to get to all the questions in Q&A. So with that, Tom, I'll turn it over to you.

Thank you very much, Robbie, and appreciate you having the access for the company today. I'm delighted to give an update on Glaukos Corporation and really want to talk about from the inception of this company, our mission has been to transform glaucoma therapy. And in doing so, we founded an entirely new category within ophthalmology called MIGS. And we also created a portfolio of devices to serve glaucoma patients all the way from nascent glaucoma through refractory disease. But our ambitions and aspirations have always been larger. And today, we seek to create the next formidable, comprehensive eye care leader in ophthalmology. Next slide. This is a disclaimer, talking about our forward-looking statements. Let's go to Slide 3. We are building a world-class global Infrastructure and company, and we've seen tremendous progress since our IPO in 2015. And a testament -- recent testament to that performance has been our preannouncement of our quarter 4 2020 unaudited revenues. And these revenues exceeded our expectations across the board. And so it shows a great recovery against a very phenomenal headwind of COVID. Our gross margins continue to be highly robust, and we are generating gross margins at the end of quarter 3 2020 of 85%. And we continue to focus on the health of our balance sheet while we fund an extraordinary number of organic programs. We've been able to preserve the balance sheet. And in so doing, too, we're able to take down a $250 million debt offering this past year to allow us to play offense through the planning cycle. We transformed our company from a North American company really into an embryonic worldwide leader, and we diversified our revenue both by geography and by franchise. Slide 4. We had a number of major accomplishments during 2020, and I'll talk a few -- highlight a few during the course of the presentation. The first was the establishment of the corneal health franchise, where we completed really a seamless integration of the Avedro business into Glaukos, and we delivered record Photrexa revenue and box sales in the category, setting up a real strong foundation for growth in the corneal health segment. We successfully launched our iStent inject W product in the United States, followed by -- following a successful launch in Europe. And this product is performing as advertised: highly predictable, highly facile. We had a swift and effective response to the COVID pandemic. We first sought to protect our employees' safety and health. We wanted to preserve jobs, and we wanted to be -- stay in touch with our customer. We did all 3 during the course of the pandemic, and we actually reduced our annual cost by over $25 million. We've had strong growth in international with some nice pocketed wins in Australia and Japan on the regulatory side. And we continue to make strong progress in getting widespread reimbursement, both on the glaucoma side and on the corneal health side, where now we have 96% of commercial payers that are covering the Photrexa bioactive drug. We've also made substantial progress in advancing our market expanding profile. We're going to talk about that during the course of the presentation today. So Slide 5. We are a company that's set to become a unique vision care leader, focusing on 3 major platforms: in microsurgical devices, in pharmaceuticals, and biosensors, as we create this hybrid surgical medical device and surgical pharmaceutical company to be able to go after the 3 major areas and classes within ophthalmology: glaucoma, corneal health and retinal disease. Slide 6. These therapeutic classes happen to be the most prominent classes within ophthalmology. Glaucoma, a $13 billion estimated global market; corneal health with keratoconus ocular surface disease and refractive conditions like presbyopia and low myopia centered at approximately $23 billion estimated marketplace. And when we look at retinal disease with proliferative retinal diseases like wet AMD, DME and RVO, we're looking at a current $13 billion global marketplace. So we're going to focus today on catalysts. And the first, across the board in glaucoma within cornea health and within retina, but let's focus on glaucoma first. Let's move to Slide 8, talk about iStent infinite. This is a powerful stand-alone MIGS product, where we're looking to submit this product in the course of the first half of this year and targeting late approval in 2021. This is our 3-stent wide flange version of the iStent inject, and this goes into a very tiny cannula where these products are injected into the eye to give greater than a 6-hour -- clock-hour access to the episcleral venous system to diminish and to reduce intraocular pressure. We conducted a U.S. clinical trial and U.S. IDE open-label single-arm study with the stand-alone procedure. 72 patients with open-angle glaucoma were uncontrolled by prior surgical or medical therapy, and we finished enrollment in the latter part of 2019. And our focus was on patient achievement of 20% or greater reduction in the mean diurnal IOP from baseline at 12 months on the same or on fewer medication. And the results, I believe, are outstanding. The results came in, and these are the most difficult-to-treat patients. They're on an average of 3 medications preoperatively or prescreening. And they've already failed on an average of 2 prior glaucoma surgeries. And even with that, just 3 stents in a trabecular bypass procedure achieved 76% of patients had 20% or greater reductions in the mean diurnal IOP from baseline on the same or fewer medications. Over 50% of these patients achieved a 30% or greater reduction in mean diurnal IOP. And even with that, these patients were reducing their overall Medicare or their mean reduction in medication burden. So you're looking at a product that's performing similarly to some of the late-stage filtration procedures but with a highly favorable safety profile. There were no explants, infections or device-related interventions or hypotony. So this product is a truly compelling new offering. It's a 3-stent injectable alternative, Slide 10, which will offer us an entirely new advent in the stand-alone community. We do believe that surgeons will use this algorithmically, use this product in progressive patients and patients who have advanced disease before they turn to late-stage filtration procedures. But glaucoma is a progressive disease, and we know there will always be a need for late-stage procedures. And so we've established a relationship, a commercial relationship with Santen to launch the PreserFlo device. And this is an 8.5-millimeter tube made of a very biocompatible material. These 2 vents to the subconjunctival space creates a bleb, but it is an alternative, an attractive alternative to trabeculectomy, tubes, XEN and ExPress. It's demonstrated strong IOP reductions in clinical study of greater than 30% and strong reductions in mean medication burden of 2.4 meds. So it's a highly safe and effective late-stage filtration procedure. We're anticipating commercial approval and launch in the second quarter of this year, and there already is a Category I code established, 66183, that we'll be able to move into to get rapid adoption. So an exciting capstone to our glaucoma treatment algorithm. But we're patient-centric, and we're focused on a full algorithm within glaucoma, and so we want to create every tool in the toolkit available for surgeons to be able to diminish and to reach the target IOP pressures to reduce or eliminate progression in glaucoma. So we're in the late-stage development of a new viscodelivery device, which is a minimally invasive system that will further support the needs of physicians and patients. And we see this as a highly complementary offering in our algorithm used either as a stand-alone procedure or, even more importantly, as a combinatorial treatment for reducing IOP. It's a development stage program, not yet FDA-approved. So when you look, Slide 13, at our comprehensive tissue-sparing portfolio, I think we've delivered on what we said we would do, more than delivered. We have products that cover every stage of progression from nascent glaucoma all the way through late-stage refractory procedures, and we'll use these to be able to provide leverage in the commercial community as well as serve patients going forward. Slide 14. But the next exciting stage in interventional glaucoma is sustained release pharmaceuticals, and we know that topical drugs are subject to significant issues of patients' noncompliance and impositions to quality of life as long and as well as ocular surface disease and toxicity. There's a clearly huge unmet need and an appetite from clinicians for an intracameral long-term delivery system. And the current mobile intracameral bio-erodible implants are limited by endothelial cell loss, labeling restrictions and relatively short durations of activity. So we've come up with the iDose TR, which is a small, tiny vessel, which contains a proprietary form of the prostaglandin travoprost, which releases drug at a [indiscernible] elution rate over a sustained period of time. This product is anchored in the trabecular meshwork. It's very facile in implantation and in removal. We're already in late-stage Phase III clinical trials, and we already have an approved Category III code for both the implantation and for the removal of this device. And our TAM and estimated initial opportunity in the United States is around 3 million eyes. So as we go to Slide 15 and we look at the data, this really is phenomenal data and greater than anyone's expectation. But it does confirm what I've been telling the community, that we've looked at the data, and we like what we see. This is the interim cohort analysis of a 154-patient trial, multicenter, randomized, double-blind trial, which is a 3-year trial that we're reporting on the 2-year data. We evaluated the 2 iDose models with a fast elution and a slow elution cohort versus topical timolol applied twice a day, and we look for noninferiority. Additional medications were added only when patients were above 18 millimeters. And remember what I've said all along. In this category, we were looking for a 6-month viable product that we had to have to commercialize. We wanted to have 12 months as the ideal. And look at the data we've been able to show and generate today, data out to 2 years showing substantial equivalence to timolol and really, really profound reductions in intraocular pressure. So this is Slide 16, a product that experienced robust IOP lowering over the 24 months and did so using similar numbers of protocol [ medicated ] medications. Slide 17. So if we take a closer look at the data from another perspective, when we look at average IOP reduction from baseline, we see, again, comparability with timolol over the course of this 2-year data analysis. Interestingly enough, on the right-hand side graph, we see that when we -- just the phenomenal, fundamental, robust changes that occur in patients, particularly with this iDose cohorts achieving pressures that are greater than 40% versus what we saw in the timolol arm. So we will see these kind of profound pressure gradient reductions using this intracameral device. So slide -- let's go to Slide 18. This is a potential game-changing device then. It's designed to address the primary shortcomings of existing glaucoma topical and intracameral therapies. It's 24/7 compliance for the patient. It's a fixed implant placement, which is going to improve the safety for the corneal endothelium. You'll see on the right-hand side of the slide, if we looked at an analysis of how many drops per eye it took the timolol cohort to achieve what a single administration of iDose did, it was 1,460, and we're continuing to follow the data. For patients on one IOP lowering pre-study medication, iDose demonstrated a greater IOP reduction versus the prestudy IOP lowering eyedrops. You'll see more of that data in peer-review studies as we go forward. And then exceedingly importantly, iDose showed no clinically significant corneal endothelial cell loss, no serious corneal adverse events and no conjunctival hyperemia. And you're all aware that in the marketplace with topical prostaglandins, we can see rates from 30% to 50% on throwing out a sequelae of topical hyperemia. So this product has performed better than advertised. We're continuing to follow these patients through 3 years, and when that 3-year data is available, I'll be happy to present it. It's incumbent upon us then to exploit the opportunity in the platform, and we're doing so by virtue of introducing a second-generation, iDose TREX, which is an extended form of the iDose predicate. It contains nearly twice the amount of medication as iDose with the potential to double the duration of effect. And we also are looking at a different -- at other APIs like ROCK inhibitors, which have shown substantial ability to have an additive effect on top of prostaglandins. We continue to look for the most promising low nanomolar concentration, highly insoluble and long-term stable ROCK inhibitor to place in this iDose platform. So stay tuned while we're making significant progress in this area as well. So let's move to Slide 20. We are creating a vision care leader. Slide 21. Let's talk now about what we're doing within corneal health and within retinal disease and focus on these areas and what the catalysts may be in 2021. Slide 22. You've already seen what we've done with Photrexa, recording record sales over the course of this year, both in the bioactive drug and in the corneal cross-linking boxes. We're moving now into Epi-On, which does not require -- this procedure does not require the removal of the corneal epithelium; should reduce treatment time in patients and improve their comfort and recovery. And we've also moved to a very, very strong contract manufacturer organization and upgraded that to pass the preapproval inspection from the FDA and provide a very stable commercial product and scale of commercial launch. We are targeting NDA filing in 2022 for this product and are excited about the possibilities moving forward. We also are working on a new laser system and a personalized treatment algorithm and proprietary chemical entity to be able to buttress and continue our dominance in the keratoconus space and perhaps move cross-linking onto other areas like presbyopia, low myopia and other areas that we continue to look at. So an exciting first year in iLink therapy and stay tuned for how we move forward. Within cornea, we also have in-licensed a proprietary novel corneal cream, which has shown tremendous early pilot data for the treatment of dry eye. And we are hopeful that this new cream becomes a transdermal platform for glaucoma and for other anterior segment diseases moving forward. So an exciting, terribly exciting, terribly early platform for growth within Glaukos. And finally, in the area of retinal disease, Slide 23. I would characterize these programs as embryonic, but exciting. The first product that we have is the triamcinolone acetonide product, which is formulated to last for a 6-month period, which will -- if approved, will compete in a $400 million-plus global marketplace. And we also are taking 2 shots on goal with products to treat proliferative intraretinal diseases. One, a multi-kinase inhibitor, which is a small molecule, which will be formulated to deliver product over a 6 to 12 month period; and we're also looking at an anti-VEGF, kind of a cross-linked sequestering [ cocoon ] which will hold in a protein to be able to deliver effective treatment over a 6-month period. And you can see from the graphs below, we're seeing some exciting early data in translational models of persistent retinal vessel leakage. So let's move to Slide 24. This pipeline is rich. If we look across the board, we're including 14 candidates by microsurgical device and pharmaceutical, along with some embryonic work and IOP sensor. We also have a number of different products that are under the hood. So as you look at this company, I think we are becoming transcendent. And I think we have the amount of products -- very, very compelling products in the pipeline, that will provide sustained growth through the next decade and into the 2030s. So let's move to Slide 25. If we look at the cascade of this promising commercial development and launch, we can envision exciting growth through the planning period and beyond. And so we've talked about having PreserFlo and iStent infinite in the 2021-'22 period. We are looking at iDose TR in 2023, as we've talked about, with some of the delays with the recruitment due to COVID, but you've seen the data and know what to expect. And we're looking at iDose TREX to follow on closely after the iDose TR product. We'll look for iLink Epi-On in 2023 and iStent SA in the 2023 to 2024 period. Beyond that, we look at dry eye therapy, iDose Rock, IOP Sensor, iLink Epi-On next generation and retinal disease programs, which gives us a more than healthy nucleus to move the business forward. So when you examine the promise of all the work that we're undertaking, it is clear that we're on our way to become the next formidable, comprehensive eye care leader in ophthalmology. And with that, I thank you and conclude this course of this presentation.

Great. Well, thanks, Tom, and I know we're going to have some more from the management team join as well. We got Joe Gilliam, CFO; and Chris Calcaterra. Chris, I'm not sure of the official title. I just call you the sales guru for Glaukos. So look, Tom, there's a ton of new information here. Maybe we can start off with the quarter and walk us through what ended up happening versus when you gave guidance. And how does that break down between the glaucoma business and the retinal business?

I appreciate that, Robbie. Joe, why don't you take this first one?

Sure. Thanks, Robbie. I think, first, from a core perspective, obviously, we didn't give guidance. We weren't in a position to really do that. We've taken the approach over the course of this pandemic to try to give as much or more information than we ever have. So you understand kind of the here and now, what's happening in our business, but we haven't been in a position to give guidance really since the beginning of the year. I would say 2 things. The first is across all the franchises, we really saw an outperformance versus our expectations, right? Second, it was probably a little bit more weighted towards corneal health in terms of the magnitude of the outperformance, and that has a lot to do with site of service and the patients that you're treating. So when you think about the average patient in the keratoconus product lines, they tend to be younger, younger parents and being treated -- and being treated in a site of services that's the physician office, so further away from the hospital. Whereas the glaucoma business globally is more exposed to older patients and hospital-based procedures. So you'd expect, obviously, the resurging dynamics of COVID to play a little bigger role there.

Great. Maybe as you think about trends throughout the quarter, we've heard from others outside of the eye care space that October was a decent quarter, November started to deteriorate a little bit, and December was a worse quarter. Does that apply to Glaukos as well? Or did you experience different trends?

I wouldn't say it exactly like that. What I would say is October was definitely probably the strongest period. November saw a little bit of increased volatility. We actually saw a little bit of a rebound in the beginning half of December, so a little bit of positive momentum. And then the second half of December saw a little bit underperformance maybe versus expectations. So the net of it was, I think the way we'd characterize it, there was a lot more volatility week in and week out over the course of the quarter than we're used to experiencing in our business. And I think that's obviously reflective of the changing dynamics that were happening from a COVID standpoint globally.

And obviously, these are outpatient procedures. Patients don't have any sort of stays, and it's mostly outside of the hospital, correct? So as you think about this, is -- are you seeing the iStent trends track in line with cataract surgeries? Or are you seeing any divergence in the historical attach rate?

Well, so first, maybe if Chris or Tom want to comment, they can. You have a split between the businesses. So obviously, in the corneal health franchise, it's almost entirely in the physician office and really away from that hospital. In the glaucoma franchise, it matters depending upon the market. But in the United States, it tends to be 80%, 85% in the ambulatory surgery center setting and away from the hospital, 15% to 20% in the hospital. Chris, Tom, do you want to comment on the rest?

Nothing to add.

Chris?

I don't have anything else to add.

All right. Well, maybe -- I also want to encourage the audience. Feel free to submit questions if you have any. But clearly, we've been waiting to see the iDose extended Phase II data. I think it was right about 2 years ago, we saw the 1-year data, and now we get a look at the 2-year data, and what we see is stability. And that's clearly a positive sign. As you look out to the Phase III trial, it's a 3-month efficacy, 12-month safety endpoint, but the goal all along has been for a longer duration effect. We now see it out to 2 years. So a couple of questions here. Tom, as we think about this, the Phase II, is that the same device that's used in the Phase III? And now seeing the 2-year data, I imagine you have 3-year data in patients and probably several years in other patients. How long can the product last for?

That's a great question. So to answer your first question, yes, it's the same device that we used in Phase II that we're using in Phase III, and these are held to very discrete elution rate analysis. And so we expect these to perform similarly in both of those studies. It's difficult to say how long the product will last. We know that we're going to track the patients in the Phase IIb study for 3 years. And we're in the course of kind of analyzing that data and will be over the course of this year. And so I'm hopeful that we'll see some very powerful signs of the Phase II data at 3 years, much like we've seen at 2 years. We know that there's enough juice, enough API in the small vessel to go to 3 years or beyond. We just don't know and can't calculate any rate of degradation that might happen in situ from the parent compound into inactive ketone analogs. But I'm highly encouraged that at 2 years, we're seeing such a profoundly stable and comparable data set that we would see with timolol, and I think that this will resonate completely with the glaucoma community and with the general ophthalmic community.

So let's spend a minute on that because for those who have been following along, we know that the rate of red eye, at least at the 1 year was 0, I believe, versus 30%, 40% in the control arm, and that's a big side effect that patients don't like. But the -- from people that have been following the product, we know that having 100% compliance is phenomenal because not everybody uses these drops, sometimes twice a day or more every day as prescribed, and compliance is very low. So in clinical trials, it's usually better. Real life, it's a lot worse. So for those that maybe look at the Phase II data here and say just, "Well, it looks the same at 2 years," what's the response?

Well, I think you helped me with the response. The timolol -- if you look at timolol and you look at any of the adherence studies over time, you will find that patients typically are religious on taking their medications anywhere from about 25% to 50% of the time depending upon what study you use. So I've said all along that these studies work in clinical trials, but in the real world, they only work if patients take them. And we know from substantive studies, both prospectively and retrospectively, that patients don't take their medications. I think one of the things that you mentioned earlier has been the biggest surprise for me. And in fact, if you read back on some of the former transcripts, I have said that I would expect to see hyperemia and hyperchromia with the iDose device similar to what we see with topical prostaglandins. Interestingly, that doesn't appear to be any of a side effect whatsoever. And so when you're looking at topical prostaglandins, which are the mainstay of therapy for the treatment of glaucoma that are throwing off 30% to 50% rates of conjunctival hyperemia, and you have a single injection of a product like this, which could eliminate that and give 24/7 compliance control, I think we're in awesome shape for commercial launch.

And is that still rate at 0% at 2 years in the Phase II data?

Yes, that's right. And in fact, if you saw in the deck, we didn't have any instances that we could see of adverse events of either hyperchromia or of conjunctival hyperemia.

So Tom, I guess the next question, and we'll get to timing, is reimbursement, right? So how should investors think about reimbursement here? Because on the one hand, it does provide compliance. It does add to the system, but it is a stand-alone procedure, and generics [ are in a ] terribly expensive at this point for the prostaglandin. So how are you thinking about reimbursement? And what's a good baseline for investors to pin to their models here?

Well, what I would tell you is that, clearly, we're doing all the pharmacoeconomic work to be able to substantiate a pricing, which we have not yet determined for what iDose will be on the commercial marketplace. But let me give you some notes for optimism. When we look at what we've already accomplished, we have already a Category III code, which is going to pay for the professional fee side for the device, which will be effective midyear this year. We also have a Category III code that's been established to be able to explant the device, which will give additional impetus and incentive for surgeons to use the product. We have a great ability to be able to create a separate J-code which is carved out from the APC assignment, and we will do so upon commercial launch. When you look at pricing, I would look to where Allergan is right now. And the numbers, we're still trying to pinpoint down, but I've been told anywhere anecdotally from $1,500 to $2,000 for an implant that's lasting for 3 to 4 months, potentially up to 6 months in some patients. Clearly, we will use that as a predicate for how we go into understanding how we will use and how we will price the iDose product. Make no mistake. It will not be proportional. I'm not making any inclination towards that, but I think it becomes a good predicate device product for how we might approach and how we go to marketplace. So I think with the predicates established, with the ability for us to do the pharmacoeconomic analysis that we'll undertake prior to launch, I think we'll be in a good position to be able to make a forceful case to payers to be able to use this device for the long term.

Great. And how should we layer on top of that the fact that the Allergan is used in the office, and yours is going to be in a surgical setting? Does that mean it should argue for more money, less money, different, not relevant?

Well, I'd probably say the latter. I would say that remember that we're fairly agnostic on where the iDose will be used. It can either be used in the ASC. And we even have surgeons now in the clinical trial that are using it in a minor surgical suite. And so it's contemplated that this product may move quickly into the minor surgical suite in an in-office setting. And as I've talked to you about before, Robbie, we're working on fundamental ways to improve the implantation technique and design to be able to get surgeons to be able to make that migration. So in the end, I want the surgeons to have the opportunity to do both, to do it either in a minor surgical suite or in the ASC.

Great. A couple of questions that have come in from the audience. Tom, the time line on iDose Phase III submission and approval got pushed out to 2022 and 2023. So the question is really, this is not the first delay in the program. What's taking so long? And how confident are you in a 2023 approval at this point?

Well, I guess I would take issue with that statement. I think this is the first delay that I'm aware of in the program. We had talked about having this product available in the 2022 period as a base case from the very beginning, really now going back 3 to 4 years. And I've also indicated that pre-COVID, we were ahead of our target being able to recruit the full clinical trial. So COVID happened. It slowed down substantially the trial. We've made considerable progress against the headwind of COVID, and I feel confident that we will be able to bring this product to marketplace in 2023.

Got it. Another question, maybe for Chris or Tom. Jumping back to the original -- not Tom. Joe. Were monthly trends overseas versus U.S. different and were there varying impacts in geography by -- on COVID?

You want me to start, Chris? And you can add color? Yes, I think the trends that we were referencing or that I referenced in the first answer largely held true internationally from an overall standpoint. There were a lot more moving parts. Obviously, that's a lot of different geographies. The timing of when you saw certain impacts to, say, Japan versus Europe with the resurgent dynamics in France, the U.K., Spain, et cetera, were a little bit different in terms of how they were playing out over the course of the quarter. But big picture, similar, where you saw a little bit more volatility, week in and week out across that business. And certainly, at the end of the year, over the holiday season, you saw a little bit more softness than we're used to.

The only color I'll add to that is you definitely saw more volatility in the markets that were more hospital-based than ASC-based. So that would include the U.K., as an example, being probably harder hit than anybody else.

A couple more here. Joe, not everyone has announced their results yet, and it's still early. Is there any way to say how Glaukos trended in glaucoma versus the market? And is there any update on the timing of the Ivantis litigation?

Well, I can start there in saying -- I just think what we've said for the last couple of quarters is increasing stability from a market standpoint. There's a lot of drivers there, including COVID, but I think there's a general positive momentum from our standpoint in the overall market as we enter into 2021.

And just to answer your question, Robbie, the trial date with Ivantis, because of COVID, has been moved from March to the end of September of this year.

Okay. That's helpful. Another question here. Tom, you got 2 products going after the more severe glaucoma with the PreserFlo and iStent infinite. What's the thought process behind having 2 different products in the same potential market? Do they compete with each other? Or are they addressing different patients?

Yes. I think they, rather than addressing different patients, they're addressing different stages of disease progression. So even though we're in the refractory category for patients who have failed on multiple medication therapy, I think most surgeons will turn algorithmically first to the iStent infinite because of its superlative track record on efficacy and safety. But then I do recognize that glaucoma is a progressive disease. There's always going to be a need for a late-stage filtration procedure like trabeculectomy, like a XEN product or an ExPress. And so that's where I would position the PreserFlo device. And as you know, Robbie, in your channel checks and others, this device seems to have won the hearts and minds of the glaucoma specialists. They're waiting for it avidly, and we're very happy to be able to partner with Santen to introduce that product this year.

Well, we definitely don't have time to get into all of the retinal disease programs. I would tell people to take a look at that slide. But I do want to sneak in an Epi-On question. This is data that I believe we're going to be getting later this year. How do you want to set expectations for this? You have really good efficacy with Epi-Off. Epi-On, you don't remove the epithelial cells. You use an oxygen-enriched glasses environment, so it's much less painful and more comfortable for the patient. Should we expect the same sort of efficacy with Epi-On as with Epi-Off? Is that a reasonable base case?

Yes. So what I would say is that, again, we'll be analyzing the data over the course of the next several months. And I would project, just based on what I've seen from some of the studies that have been done in Europe and elsewhere, again, the most important thing is that we meet the primary efficacy end point for commercial approval, right? And I have a high expectation we'll be able to do that. Having said that, I would expect Epi-On at best case to perform as well as the Epi-Off product simply because you aren't removing the epithelium. You're relying on the surfactant to be able to penetrate the corneal epithelium to reach the stroma. So I would not be surprised if the efficacy is profound with Epi-On but maybe not quite as good as what we see with Epi-Off.

I remember before you acquired Avedro, we led the IPO, and I remember them talking about potentially titrating efficacy for maybe very early patients with less severe disease. Epi-On, it's much less painful. And then for those with a bit more severe disease, Epi-Off; temporary pain, but maybe a bit more efficacy. So I'm glad to see consistency.

Yes, I think so, too. I mean, if the data turn out that way, it gives us a great bifurcated approach to the marketplace. Allows us to pivot and swing in a number of ways which will be beneficial.

Great. Well, unfortunately, we're out of time. We didn't get to talk about everything, but I really appreciate the productive conversation and look forward to 2021 and all it brings.

Thank you very much, Robbie.

Right. Thanks, everyone.

Thanks, Robbie.